Knowledge Grows for mAb Development

Since the first product licensed in 1986, monoclonal antibodies,
also referred to as “mAbs,” have dominated the field of biopharmaceuticals
with more than 70 products approved, and hundreds
more currently under clinical evaluation. Market evaluations for
these products predict continued interest for years to come.

The knowledge gained over decades of discovery research, development
and manufacturing has enabled tremendous advancements
in the commercialization of therapeutic monoclonal
antibodies. In addition to fully human and humanized monoclonal
antibodies, new related modalities have been introduced, such
as antibody fragments, Fc-fusions, bi-specifics and antibody drug
conjugates, all aimed at improving pharmacological properties.
Technological improvements in expression systems, cell culture
and downstream purification have increased productivity. The
ability to apply common unit operations across multiple monoclonal
antibodies has allowed manufacturers to develop platform
processes and, in turn, accumulate substantial knowledge to
apply to future molecules in their portfolios. Many companies are
now adopting continuous manufacturing approaches to further
streamline production and reduce operating expenses.

With so much accumulated knowledge related to monoclonal
antibodies, the focus is now on how best to make use of all that
information. The term “prior knowledge” describes this wealth of
information—a hot topic among industry and regulators. With
this in mind, the program planning committee behind the 11th
Workshop on Monoclonal Antibodies selected prior knowledge as
this year’s theme. The key objective of the workshop will be to
answer questions on how process knowledge is being captured,
transferred and, more importantly, how it can be used to drive
continuous improvements, sustaining further advancements for
this therapeutic class of products.

Workshop sessions will cover a variety of topics related to prior
knowledge from research, development, manufacturing and regulation.
Through presentations, case studies and panel discussions,
workshop participants will learn the latest trends in applying prior
knowledge to monoclonal antibodies. In addition to the planned
sessions, the program will provide abundant opportunities to network
and exchange ideas with regulators and industry leaders.